Structured Online Contraceptive Counseling (LOWE Trial) at Emergency Contraception (EC) Pharmacy Provision LOWE+EC=LOWEC

Contraception Clinical Trial

— LOWEC  

Official title:

Structured Online Contraceptive Counseling at Emergency Contraception Pharmacy Provision - A Cluster Randomized Crossover Trial - (The LOWEC Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299475
• Other study ID #: 2023-06755-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Kristina Gemzell Dannielsson, PhD
• Phone: +46 (0)72 254 23 85
• Email: kristina.gemzell[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP).

Description:

This pragmatic cluster randomised cross-over controlled trial aims to determine whether the composite intervention of online contraceptive counseling at the time of a pharmacy provision of emergency contraceptive pill (ECP), plus an invitation to a sexual and reproductive health clinic, will result in increased use of subsequent effective contraception (hormonal or intrauterine) compared with standard care. The study will be conducted at approximately 30 pharmacies in the Stockholm Region. Clients who will buy an ECP (without prescription) at one of these pharmacies will be invited by posters and pharmacy personnel to participate in the study. By scanning a quick response (QR) code they will receive more information about the study. Eligible women who choose to participate in the study and give their consent will be allocated to intervention or control group depending on the visited pharmacy's allocation. Participants at the intervention pharmacies will receive an intervention package with online structured contraceptive counseling followed by an online invitation to a clinic for contraceptive provision. While participants at the control pharmacies will purchase the ECP without any further guidance. The order in which the pharmacies will provide the intervention or control will be randomly assigned at a ratio 1:1 by an independent statistician. The recruitment will halter for an intervening period of at least two weeks when the pharmacies switch to the new group depending on their first allocation (cross-over). An online baseline questionnaire and follow-up questionnaires will be collected at 1 and 12 months following the ECP provision for participants both from intervention and control pharmacies. The randomized controlled trial will be conducted together with a process evaluation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: September 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Women >/=15 years visiting a pharmacy to buy ECP for her own use
• Has a smartphone with an electronic identification and ability to scan a QR code
• Ability to read Swedish or English
• Willing and able to provide informed consent
• Willing to participate in the follow-up

Exclusion Criteria:

• Ongoing pregnancy

Related Conditions & MeSH terms

• Contraception
• Emergencies

Intervention

Other:
• Online counseling and invitation
Online counseling - An educational video including contraceptive models, four key questions and an effectiveness chart (the LOWE intervention material). Invitation to a clinic - access by weblinks to a regional or national website

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	the Swedish Pharmacy Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of effective contraception	Participant´s self-reported use in a digital questionnaire of regular effective contraception (hormonal or intrauterine)	at 1 month follow-up from the pharmacy visit
Secondary	Contraceptive use	Contraceptive use, including long-acting reversible contraception (LARC) (self-reported use in a digital questionnaire)	within 12 months follow-up
Secondary	Incidence of pregnancy and abortion	Pregnancy and abortion (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up)	within 12 months follow-up
Secondary	Satisfaction with the intervention	Participants' satisfaction with the intervention package (self-reported use in a digital questionnaire) Assessed as: very satisfied, satisfied, neither nor, dissatisfied, very dissatisfied	At 1 month follow-up from the pharmacy visit
Secondary	Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups	Contraceptive use, pregnancy, abortion and satisfaction in vulnerable groups such as youths and migrants, compared to non-migrants and older participants (self-reported use in a digital questionnaire or scrutinized medical record, if lost to follow-up)	within 12 months follow-up
Secondary	Process evaluation	How context affects the implementation and outcomes among participants and pharmacy personnel (individual interviews)	within 12 months follow-up